Senior Specialist, MSAT Validation & LCM
Core
Provides process validation and Lifecycle Management support for the Leiden Cell Therapy Facility, ensuring safe and compliant cGMP operations for cell therapy manufacturing.
Role type
Senior Specialist, Process Validation & Lifecycle Management (Cell Therapy)
Builds
Commercial manufacturing capabilities for multi-product Cell Therapy
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing
Required skills
cGMP knowledge, facility/clean room design, process validation, aseptic process simulations (APS/APV), process performance qualifications (PPQ), data analysis/statistics, risk mitigation, change control management, regulatory inspection readiness
Preferred skills
Advanced degree in science/engineering/biochemistry, experience with pre-licensure inspections (PLIs)
Technologies
cGMP regulations, validation protocols, statistical analysis tools
Responsibilities
Execute Aseptic Process Simulations/Validations (APS/APV) and Process Performance Qualifications (PPQ), design and execute test plans for investigations, lead site Change Controls, support equipment and facility commissioning/qualification, author qualification/validation documents, support global change controls, maintain inspection readiness
Seniority
Senior, hands-on IC